Years of Experience
Date Last Verified
Clinical Site Agreement Consultant The candidate will provide expert advice and support to assist in the development, preparation and negotiation of Clinical Site Agreements (CSAs). Will be responsible for defining the processes and optimising the tools and resources that will facilitate the negotiation and execution of final CSAs by GRO functions. Research and document the legal, regulatory and procedural mechanisms associated with execution of CSAs across the range of countries that the company operates in. Ensure that the company's concepts and principles are adhered to in the CSA execution process. Develop and maintain a library of country CSA templates that will satisfy the requirements of all parties involved (the company, Sponsor, Sites and Ethics Committees) and promote efficient execution. Liaise with Client Sponsors on CSA strategy and promote measures to have agreed processes, templates and guidance documents developed and in place 'ahead of the game. Guide and advise SCS on: prioritisation of CSAs by country based on critical path analysis of Start-up procedures - best approaches to problem situations that arise within various Projects. Provide CSA strategy and input into Client Proposals, Contracts and RFIs. Develop Site Grant budgets across the range of countries for Client Proposals (pass-through fees) and/or Client Contracts (pass-through fees). Interact with Patient Recruitment and Feasibility Evaluation Groups and provide feedback on ease of contracting across the range of countries and sites.
Qualification and Experience
The candidate should have a degree in life sciences, law, business or equivalent. Must have several years work experience, preferably in clinical contracting, pharmaceutical contracting legal (paralegal) OR a combination of work experience and education may substitute for some requirements in each qualification area. Should have knowledge of MS Office, Excel and windows-based email systems.
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